Key result
Trifecta yields ~2 mm Hg lower mean pressure gradients and larger orifice areas vs Perimount Magna Ease.
Why the study?
Modern supraannular aortic xenografts offer improved hemodynamics, but a prospective randomized comparison of Trifecta and Perimount Magna Ease valves based on metric annulus sizing was lacking.
Does the Trifecta valve improve hemodynamic performance compared to the Perimount Magna Ease valve in patients undergoing aortic valve replacement for aortic stenosis?
RCT (n=100)
stratified intraoperative randomization
Does the Trifecta valve improve hemodynamic performance compared to the Perimount Magna Ease valve in patients undergoing aortic valve replacement for aortic stenosis?
Absolute Event Rate: 10.8% vs 13.2%
p-value: p=0.02
Both Trifecta and Perimount Magna Ease bioprostheses provide excellent hemodynamics, with Trifecta demonstrating early superiority in effective orifice area and pressure gradients, particularly in patients with larger annuli.
Trifecta may be preferred for optimized early hemodynamics in AVR; extends randomized comparisons versus Perimount Magna Ease.
Background Modern supraannular aortic xenografts offer a special design, thus providing maximized opening area for improved hemodynamics. The aim of this study was a prospectively randomized comparison of the Trifecta and the Perimount Magna Ease valves based on metric annulus sizing. Methods A total of 100 patients with aortic stenosis undergoing aortic valve replacement (AVR) with or without concomitant procedures were prospectively included. After decalcification of the annulus, stratified intraoperative randomization was performed. The diameter of the aortic annulus was measured using metric Hegar dilators and randomization was based on this metric annulus diameter. Exercise echocardiography was performed at 10-month follow-up. Results Mean age was 69 years, with 36% female. Predominant implanted valve sizes were 23 mm (39%) and 25 mm (32%). Unadjusted mean pressure gradient was significantly lower and effective orifice area larger for the Trifecta group (10.8 ± 5 vs. 13.2 ± 4 mm Hg, p = 0.02 and 1.93 ± 0.39 vs. 1.70 ± 0.30 cm2, p = 0.002) at discharge. In patients with small annuli, based on the metric annulus size there were no significant differences in gradients or the orifice area. At exercise echocardiography follow-up, there were no significant hemodynamic differences between both prostheses. Conclusions The Trifecta and the Perimount Magna Ease prostheses both show excellent hemodynamic performance after AVR. In patients with larger annuli, the Trifecta valve seems to be even superior to the Magna Ease, which may be advantageous in obese patients.
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Linden et al. (2018) conducted an RCT in aortic stenosis (n=100). Trifecta valve vs. Perimount Magna Ease valve was evaluated on mean pressure gradient at discharge (p=0.02). The Trifecta valve resulted in a significantly lower mean pressure gradient (10.8 vs 13.2 mm Hg, p=0.02) and larger effective orifice area than the Perimount Magna Ease valve at discharge.
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